510(k) Report

Devices descending from K221257

4 later devices reach SpectraWAVE Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.20250—
+1K243016Starlight Imaging CatheterSpectrawave, Inc.20250—
+1K230691HyperVue™ Imaging SystemSpectrawave, Inc.20231—
+2K251198HyperVue™ SoftwareSpectrawave, Inc.20250—